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FDA 510(k)

MOUTHPIECE, UNIVERSAL

K-Number: K790066 · 1979-02-06

ApplicantAirlife, Inc.
Decision Date1979-02-06
Product CodeBYP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MOUTHPIECE, UNIVERSAL is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1979-02-06 under 510(k) number K790066. The device is classified under product code BYP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOUTHPIECE, UNIVERSAL?

MOUTHPIECE, UNIVERSAL is a medical device that received FDA 510(k) clearance on 1979-02-06. The listed applicant is Airlife, Inc.. The 510(k) number is K790066.

When did MOUTHPIECE, UNIVERSAL receive FDA 510(k) clearance?

MOUTHPIECE, UNIVERSAL received FDA 510(k) clearance on 1979-02-06, under 510(k) number K790066.

Who is the listed applicant for MOUTHPIECE, UNIVERSAL?

The FDA 510(k) record lists Airlife, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOUTHPIECE, UNIVERSAL?

The FDA product code for MOUTHPIECE, UNIVERSAL is BYP.

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Other records listing Airlife, Inc. as applicant

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K834573AQUA TRAPK834570VOLUME VENTILATOR CIRCUIT W/WATER TRAPK834077SINGLE USE NEBULIZER-ADJUST-AIR ENTRAINK833196VOLUME VENTILATOR CIRCUIT-NEBULIZERK833197TRACH SWIVE/CONNECTORK832725DUAL DIAL VENTURI STYLE MASK

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Related Devices (Code: BYP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K955657NORTH STATE PLASTICS RESPIRATORY MOUTHPIECENorth State Plastics, Inc.K944512TRUZONE PFM DISPOSABLE MOUTHPIECEMonaghan Medical Corp.K893791BREATHING MOUTHPIECEDiemolding Corp.K872037AEROCHAMBERMonaghan Medical Corp.K865093SAFE-T-SHIELD MOUTHPIECEMedi Nuclear Corp., Inc.K863049INHALATION AIDBoehringer Ingelheim Pharmaceuticals, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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